Kornimate/medical-research-clean huggingface dataset:
vitamin d for schizophrenia

Conditions: Clozapine Resistant Schizophrenia

Summary: background: despite improvements in medications, treatment delivery and rehabilitation, schizophrenia outcomes remain suboptimal. there are a proportion of 30-40% treatment-resistant schizophrenia patients. multiple lines of evidence suggest that vitamin d is a neuro-active steroid that acts on brain development, leading to alterations in brain neurochemistry and adult brain function. early deficiencies have been linked with neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been associated with adverse brain outcomes, including parkinson's disease, alzheimer's disease, depression and cognitive decline. ecological studies support a potential role for vitamin d in schizophrenia. these data include studies that have explored the association between schizophrenia and winter/spring birth and also the apparent increased incidence and prevalence of schizophrenia at higher latitudes. objective: to evaluate the effect of vitamin-d supplementation on the mental state of clozapine-treated chronic schizophrenia patients, and the relation of disease severity to serum vitamin d levels. methods: the investigators will use a prospective, interventional, longitudinal, double blinded, placebo-controlled, randomized design. the investigators will recruit 50 clozapine-treated chronic schizophrenia patients, with low level of serum vitamin-d, that will be randomly assigned (1:1 ratio) to receive either weekly oral drops of vitamin d (cholecalciferol) or oral drops of placebo for 8 weeks follow-up. repeated assessments will include: clinical severity scales (panss, cgi), side effects (sas, bars, clozapine side effects), cognitive (moca), metabolic parameters and laboratory data. patients who were assigned to placebo will be supplemented with vitamin d after the 8 weeks period, and then will be assessed again with the same protocol of vitamin d treated patients. all participants will be assessed again after 24 weeks after vitamin d initiation. analysis: the investigators will use on-way anova with repeated measures for comparison of vitamin d and control groups. the investigators will apply intention to treat and locf.


Eligibility criteria:
inclusion criteria: 1. males and females 2. age 18-65 years 3. diagnosis of schizophrenia according to dsm-iv-tr criteria, as confirmed by two senior psychiatrists 4. total panss score \> 70 5. cgi-s \> 3 6. clozapine treatment for at least 18 weeks 7. vitamin d deficiency: plasma 25-oh-vitamin d \<75 nmol/l (20-30 ng/ml) 8. able to consume oral drops of vitamin-d 9. able to sign informed consent exclusion criteria: 1. mental retardation 2. organic brain disease 3. known parathyroid disorder 4. inborn/acquired vitamin d metabolism disorders 5. patients already treated with vitamin d supplementation

Keywords: clozapine schizophrenia vitamin-d treatment-resistant
mesenchymal stem cell based therapy for the treatment of osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: the purpose of this study is to determine the safety and effectiveness of five infusions of characterized hla-identical msc in non immunosuppressed children with osteogenesis imperfecta (oi).

the principal aim of this trial is to assess the safety of non-mutated hla-identical mesenchymal stem cell (msc) transplantation for oi pediatric patients irrespective of treatment with biphosphonates. since msc are inherently non-immunogenic and do not elicit proliferation of allogeneic lymphocytes (in co-culture experiments), a cell therapy based on hla-identical or histocompatible (at least 5 shared out of 6 hla antigens) allogenic msc may be accomplished without subjecting the patients to immunosuppressor treatment. adverse secondary effects due to immunosuppressor treatment will be avoided using this strategy thus patients may benefit from two cellular infusions. the patients will be followed for 2 years post their fifth and last msc infusion.

Eligibility criteria:
inclusion criteria: * patient age: older than 6 months and younger than 12 years old. * patients with molecular confirmation of mutation in either col1a1 or col1a2 genes associated with oi (type iii). * patients with hla identical (that shared at least 5/6 antigens) siblings willing to donate bone marrow-mscs. * all patients that fulfil the inclusion criteria regardless of whether or not they are undergoing biphosphonate treatment. * patients whose parents or the legal guardians are willing to sign the consent forms to participate in this clinical trial. exclusion criteria: * patient age: older than 12 years old * patients lacking confirmation of mutation in either col1a1 or col1a2 genes associated with severe deforming oi (type iii). * other pathological subtypes of oi. * patients lacking of hla identical (that shared at least 5/6 antigens) siblings willing to donate bone marrow-mscs. * immunodeficiencies and any other malignancies. * participation in other clinical trial. * any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial. * patients whose parents or the legal guardians do not sign the consent forms

Keywords: mesenchymal stem cell based therapy cell infusion
sensor-based technology for upper limb rehabilitation

Conditions: Multiple Sclerosis

Summary: sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with multiple sclerosis (ms), especially for treating upper extremities function limitations. the sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database in order to quantitatively monitoring measures and therapy progress. the aim of this study is to evaluate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limbs functions of ms patients. the training consisting of twelve sessions of upper limb training, was compared with twelve sessions of upper limb sensory-motor training, without robotic support. both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to the conventional therapy. all patients were evaluated at baseline (t0) and after 4 weeks of training (t1)


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * upper limb deficits, * disability between 5 and 8.5 on the expanded disability status scale (edss). exclusion criteria: * modified ashworth scale (mas) \< 3 at the upper limb; * cognitive deficits affecting the ability to understand task instructions (mini-mental state examination \< 24 * medical research council (mrc) scale with score 0 or 5; * presence of clinically evaluated severe comorbidities; pregnancy; * subjects with artificial pacemaker; * subjects involved in other studies.
model 4396 left ventricular (lv) lead chronic performance study

Conditions: Heart Failure

Summary: lead survivability will be summarized.

the purpose of this study is to evaluate long-term performance of the 4396 lv lead. this evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. the leads will be followed for 5 years after implant. this study is required by fda as a condition of approval of the model 4396 lv lead. this study is conducted within medtronic's post-market surveillance platform.

Eligibility criteria:
patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. inclusion criteria * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive an attain ability model 4396 lv lead * patient within 30 day post implant enrollment window exclusion criteria * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
massive nasal bleeding in patients with npc received curative rt

Conditions: Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy

Summary: to investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (npc) patients who received curative radiotherapy (rt) with/without chemotherapy. a total of 1327 patients with previously untreated, biopsy-proven npc, and no distant metastasis were retrospective reviewed. investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. investigators compared overall survival between patients with and without massive nasal bleeding by kaplan-meier method.


Eligibility criteria:
inclusion criteria: * previously untreated, biopsy-proven npc * no distant metastasis exclusion criteria: * incomplete record of history or treatment
an extension study of jr-171-101 study in patients with mucopolysaccharidosis type i (mps i)

Conditions: Mucopolysaccharidosis I

Summary: phase i/ii, open label, multicenter, multinational (japan, brazil and the us) extension study of jr-171-101 (nct04227600) for the treatment of mps i

patients who have completed the part2 of jr-171-101 study (nct04227600) and fulfill all eligibility criteria can be enrolled in this jr-171-102 study. in the jr-171-102 study, subjects will receive either 2.0 or 4.0 mg/kg/week of jr-171 intravenously at the same doses received at week 12 of the jr-171-101 study.

Eligibility criteria:
inclusion criteria: * patients who have completed the part 2 of jr-171-101 study * a patient from whom written informed consent can be obtained. if the patient is aged under 18 years (20 years in case of japan) at the time of assent or willingness to participate in the study cannot be confirmed due to mps i-related intellectual disability, informed permission from the patient's legally acceptable representative (e.g., his/her parents or guardians) need to be obtained instead of his/her consent. even in this case, written informed consent should be obtained from the patient, wherever possible * female patient or male patient whose co-partners is of child-bearing potential agree to use a medically accepted, highly effective method of contraception, such as spermatocidal gel plus condom, an intrauterine device or oral contraceptives until one month after the final administration. exclusion criteria: * a patient who is unable to perform the study procedures, except for 6-minute walk test, neurocognitive testing, bvmt-r, hvlt-r, and t.o.v.a. * judged by the principal investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumbar puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process * judged by the principal investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or hypersensitivity to any drugs * otherwise judged by the principal investigator or subinvestigator to be ineligible to participate in the study in consideration of patient's safety

Keywords: mucopolysaccharidosis i
metanephrines in obstructive sleep apnoea

Conditions: Pheochromocytoma; Obstructive Sleep Apnea; Catecholamine; Secretion

Summary: although most patients have essential (unexplained) hypertension, some patients have a treatable underlying condition. one such condition is phaeochromocytoma, a tumour that produces excessive stress hormones. left undiagnosed, patients may develop a hypertensive crisis that can be fatal. measurements of stress hormones (both 24-hour urine collection and morning blood tests) are highly sensitive for detecting these tumours. however, these stress hormones may also be elevated in obstructive sleep apnoea (osa) which affects 1 in 5 adults. the investigators hypothesize that in patients with osa, blood tests will be better than 24-hr urine tests at ruling out a tumour. if this is confirmed, then osa patients with suspected phaeochromocytoma could be investigated with a morning blood test instead of a traditional urine test, reducing unnecessary additional tests and patient anxiety. in this single site study, the investigators plan to recruit 70 patients undergoing polysomnography. 24hr urine and bloods will be measured. patients with elevated hormone levels will undergo imaging to rule out a tumour. the primary outcome will be the accuracy of each test in ruling out a tumour. the secondary outcomes will be the relationship between stress hormone level and severity of osa, which may help to explain the increased cardiovascular risk in patients with osa, and the change in stress hormone level with treatment for osa


Eligibility criteria:
inclusion criteria: * patients aged 21-70 years attending for a sleep study to evaluate for osa exclusion criteria: * medications that can cause changes in metanephrine levels * other factors that can cause changes in metanephrine levels * renal impairment (egfr \< 60ml/min) * other serious medical conditions
evaluation of result and influence factors on composite graft in fingertip amputation

Conditions: Pinprick Sensation Diminished; Amputation, Traumatic; Pain

Summary: fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of the hands and have an aesthetic function. fingertip injuries are defined as injuries occurring distal to the insertion of the flexor and extensor tendons. these injuries are one of the most common trauma injuries presented in acute care settings, accounting for approximately 4.8 million emergency department visits per year in the united states.(1) fingertip amputations may not constitute the majority among these fingertip injuries but can have a complex spectrum of injury. in these cases, the reconstruction methodologies focus on preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail structure, achieving a well-contoured and painless fingertip, and restoring durable and sensate skin. there are so many factor that influence the result of composite graft in distal finger tip amputation. investigators will collected the data including the size of amputee , shape, level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation procedures.

fingertip amputations underwent 1. modified composite grafting with pulp adipo-fascia advance flap 2. composite graft 3. revision amputation was collected in this study follow-up was arranged in out-patient department, including: type of amputation ( hirase classification, ) 2-point discrimination test, dash(disabilities of the arm, shoulder, and hand) outcome measure, graft survival, pain evaluation with visual analog scale other associated treatment such as hyperbaric oxygen therapy length of finger shortening at 6 month after operation

Eligibility criteria:
inclusion criteria: * february 1990 and june 2015, patients received composite graft in fingertip amputation exclusion criteria: * patients refused to participate the study

Keywords: finger amputation composite graft adipo-fascia flap
epidemiological investigation of malocclusion in china

Conditions: Epidemiological Investigation; Malocclusion

Summary: malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. notably, the last comprehensive national prevalence data on malocclusion in china, which encompassed a significant sample size, dates back over two decades. given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. consequently, there is an urgent need for china to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection.

with the improvement of our country's living and cultural level, orthodontic treatment for malocclusion has emerged as a critical need that significantly impacts individuals' physical and mental wellbeing, as well as their social life in contemporary society. to obtain the prevalence rate, demand index and risk factor analysis of malocclusion in china serves as a fundamental prerequisite for effective diagnosis, identifying the optimal treatment window, and devising tailored treatment plans. the purpose of this study is as follows: 1. obtaining epidemiological data such as the prevalence rate of malocclusion is the cornerstone of prevention and treatment of malocclusion, and is also the prerequisite of carrying out a series of studies; 2. establishing china's orthodontic treatment demand index offers vital support for the advancement of orthodontics and oral healthcare.; 3. updating and enhancing x-ray head image measurement normal reference value provides a more scientific and objective foundation for orthodontic planning, improves the level of diagnosis and treatment, and fosters the development of related disciplines. the implementation of this project will not only foster an improvement in the overall oral health of the populace but also establish a scientific foundation for oral medicine research and the development of prevention and treatment strategies.

Eligibility criteria:
inclusion criteria: 1. individuals with all genders; 2. individuals with good general health; 3. individuals with no history of orthodontic treatment or other maxillofacial surgical interventions; 4. individuals who agree to and are willing to sign the informed consent form. exclusion criteria: 1. individuals diagnosed with genetic or systemic disorders; 2. individuals with a recent (within the past 3 months) history of maxillofacial trauma; 3. individuals who are incapable of undergoing oral examinations or completing the necessary questionnaires.
reprogramming to prevent progressive pacemaker-induced remodelling

Conditions: Left Ventricular Dysfunction; Heart Failure, Systolic; Left Ventricular Failure; Pacemaker; Complication, Mechanical

Summary: the aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity. this will be achieved by showing in a single centre, phase ii, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

patients (n=70) with long-term (\>2 years) permanent pacemakers with avoidable rv pacing will be invited to participate in a single-centre, phase ii, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. all participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (eq-5d-5l), blood tests and pacemaker check.

Eligibility criteria:
inclusion criteria: * chronic right ventricular bradycardia pacemaker implanted for at least 24 months * willing and able to give informed consent for the intervention exclusion criteria: * known poor imaging quality patients (details of patients excluded for this reason will be recorded) * patients with complete heart block and no reprogramming options

Keywords: pacemaker heart failure left ventricular dysfunction bradycardia remodelling
hemospray versus the combined conventional technique for endoscopic hemostasis of bleeding peptic ulcers : a pilot study

Conditions: Bleeding Peptic Ulcers

Summary: hemospray (tc-325, cook medical inc, winston-salem, nc, usa), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. the hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. the investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. patients with high-risk bleeding peptic ulcers will be treated with hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.


Eligibility criteria:
inclusion criteria: * peptic ulcer with high-risk stigmata of recent hemorrhage (forrest class ia, ib, iia and iib) exclusion criteria: * patients younger than 21 years of age * refusal to participate in study * contraindicated for endoscopy * pregnant or lactating patients * bleeding secondary to non-peptic ulcer source * patients requiring mechanical ventilation * patients with acute coronary syndrome
postoperative telerehabilitation in older adults

Conditions: Telerehabilitation; Carcinoma, Non-Small-Cell Lung; Cardiopulmonary Exercise Test

Summary: the purpose of this study is to confirm the effectiveness of a mobile messenger-based home tele-rehabilitation protocol in patients who have undergone lung resection surgery. by analyzing the difference from the existing postoperative pulmonary rehabilitation, the investigators would like to propose a new pulmonary tele-rehabilitation protocol.


Eligibility criteria:
inclusion criteria: 1. a person who is suspected of lung cancer and is scheduled to undergo a thoracoscopic lung resection surgery. 2. men and women the age ≥65 years. 3. a person who understands the course of the clinical trial and signs the informed consent form. exclusion criteria: 1. patients whose activity is restricted due to other diseases (e.g. osteoarthritis, spinal disease, cerebral infarction, etc.) 2. patients who cannot test bioimpedance analysis due to the insertion of artificial pacemakers and defibrillators 3. a person who has difficulty judging himself/herself due to dementia, etc 4. those enrolled in other clinical trials 5. a person deemed inappropriate to participate in this clinical trial under the judgement of the investigator. 6. a person who cannot use mobile messenger
bariatric surgery and pharmacokinetics of chlorprothixene

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study we investigate the pharmacokinetic effects of bariatric surgery on chlorprothixene.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics chlorprothixene